Primary Immune Deficiency Secondary Immune Deficiency
Conditions
Interventions
Trade Name: Hizentra
Product Name: Hizentra, Subcutaneous Immune Globulin (Human) (SCIg)
Product Code: IgPro20
Pharmaceutical Form: Solution for injection
INN or Proposed INN: human normal immunoglobu
Sponsors
CSL Behring, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Full study: • Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy. Pharmacokinetic substudy: • Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens. Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy. • Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 [Hizentra]) within 21 days before study entry and/or during the study. • Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject. • Women of childbearing potential with a positive pregnancy test. • Active infection at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine tolerability and safety of biweekly IgPro20 injection regimen • To assess the pharmacokinetics of weekly and biweekly IgPro20 injections;Secondary Objective: • To determine the efficacy of biweekly IgPro20 injection regimen • To evaluate the dose of biweekly IgPro20 injections needed for subjects switching from weekly IgPro20 therapy to biweekly therapy • To assess the Quality of Life of patients on biweekly IgPro20 injections;Primary end point(s): 1. Annualized rate of adverse events (local and systemic) 2. Area under the concentration-time curve, AUC(0-t ) 3. Maximal serum IgG concentration (Cmax) 4. Time to maximal serum IgG concentration (Tmax) 5. Trough serum IgG concentration (Ctrough) ;Timepoint(s) of evaluation of this end point: 1. During biweekly treatment period, up to approximately 52 weeks 2. and 5. Immediately before and after infusion, and at up to 6 time points between 1 and 14 days after infusion, for one infusion each during the weekly and biweekly treatment periods. 3. and 4. Immediately after infusion, and at up to 6 time points between 1 and 14 days after infusion, for one infusion each during the weekly and biweekly treatment periods. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Annualized rate of infections per patient 2. Serum IgG trough levels (Ctrough) 3. Health-related Quality of Life;Timepoint(s) of evaluation of this end point: 1. and 3. During weekly and biweekly treatment periods, up to approximately 64 - 76 weeks 2. Immediately before the next infusion during the weekly treatment period and on week 24 and 48 of biweekly treatment. | — |
Countries
Canada
Contacts
Public ContactTrial Registration Coordinator
CSL Behring, LLC
Outcome results
None listed